A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Proteinuric Renal Disease Clinical Trial

Official title:

A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00469625
• Other study ID #: Z # 13178
• Status: Withdrawn
• Phase: N/A
• First received: May 3, 2007
• Last updated: December 24, 2015
• Start date: July 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2015
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Description:

Objectives:

1. To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases

2. To determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo.

Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects with proteinuric renal disease (>400 mg/24 hours)

Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Stable chronic kidney disease

2. Urine protein : Creatinine ratio > 0.4

3. Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min

4. PTH (intact) >20 pg/ml and <250 pg/ml

5. Age 18-85

6. If on ACEI/ARB, then dose optimized (BP, K)

Exclusion Criteria:

1. Failure to provide informed consent

2. Glomerunephritis requiring active treatment with immunosuppresive therapy

3. Serum phosphorus > 5.2

4. Serum calcium (adjusted for albumin)> 10.0

5. Active malignancy

6. Likelihood of requiring renal replacement therapy within 1 year

7. Uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuric Renal Disease

Intervention

Drug:
• paricalcitol (initial dose 1 mcg orally per day)

Locations

Country	Name	City	State
United States	Winthrop Univ. Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States,